Quality Assurance of Pharmaceuticals - A Compendium of Guidelines and Related Materials - Volume 1
(1997; 248 pages) [French] View the PDF document
Table of Contents
Open this folder and view contentsIntroduction
Open this folder and view contents1. National drug regulation
Open this folder and view contents2. Product assessment and registration
Open this folder and view contents3. Distribution
Open this folder and view contents4. The international pharmacopoeia and related activities
Open this folder and view contents5. Basic tests
Close this folder6. Laboratory services
Close this folderNational laboratories for drug quality surveillance and control1
View the document1. Introduction
View the document2. First-stage laboratory for drug surveillance
Open this folder and view contents3. Medium-size drug control laboratory
View the document4. Scope of activity
View the document5. Factors influencing the size and location of a laboratory
Open this folder and view contents6. Implementation of control laboratory projects
Open this folder and view contentsGood laboratory practices in governmental drug control laboratories1
Open this folder and view contentsSampling procedure for industrially manufactured pharmaceuticals1
Open this folder and view contents7. International trade in pharmaceuticals
Open this folder and view contents8. Counterfeit products
Open this folder and view contents9. Training
View the documentSelected WHO publications of related interest
View the documentBack cover
 

2. First-stage laboratory for drug surveillance

This small laboratory has a floor space of 60 m2. It is staffed by one analyst, 2 technicians, and 1-2 housekeeping staff.

Such a laboratory cannot be effectively maintained as an independent unit. It should be incorporated within another governmental laboratory or be sited within a large regional hospital. This provides access to existing technical and library facilities, utilities, and supply arrangements. It is important, none the less, that the manager should remain organizationally independent in the execution of his duties, and that the laboratory should be accorded an independent budget.

It is estimated that such a laboratory could undertake annually 200-300 full analyses (samples fully tested and evaluated in accordance with quality specifications) or a greater number of partial analyses.

The analyst, who should have a proven ability to work independently, should be university trained in pharmacy or chemistry and should have received practical training in an established drug quality control laboratory for 6 months to two years, as determined by background experience. An institutional training for technicians is desirable in addition to in-service training in the laboratory.

The laboratory premises should be provided with basic utilities (water, drainage, and electricity) and equipped with a hot-water source, a distilled-water still, and a propane gas tank, if a piped gas supply is not available. If the laboratory is to be located in a newly erected building it is best constructed as a basic module that may be subsequently extended.

The laboratory furniture, which should be arranged to provide an efficient but uncongested working space, must include: one double chemical bench with two lateral sinks located in the centre of the module, a fume hood, one laboratory bench for instruments, a table for balances, one storage cabinet for solvents, one refrigerator (with freezer compartment), wall shelves, and writing desk. The bench for instruments and the table for balances are positioned in a separate part of the module to protect the instruments from corrosion.

Important items of laboratory equipment are given in Table 1. No listing of reagents or glassware is provided as such lists are best compiled within the laboratory. Provision should always be made for an adequate reserve of glassware and sundry items. This is of particular importance where difficulties in delivery are anticipated.

Table 1. First-stage laboratory for drug surveillance

Equipment and major instruments

No.

Analytical balance (four place, mechanical)

1

Spectrophotometer (UV/visible, single-beam, manual)

1

pH-meter (with electrodes)

1

Karl-Fischer titrator

1

Melting-point apparatus

1

Polarimeter (manual)

1

Drying oven

1

Vacuum oven

1

Vacuum pump

1

Centrifuge (table-top)

1

Hot plate with stirrer

3

Equipment for thin-layer chromatography including:

 
 

- spreader

1

 

- spotting equipment

1

 

- developing chambers

6

 

- spraying bottles

6

 

- UV viewing lamp

1

Disintegration test equipment

1

Microscope

1

Refrigerator (with freezer compartment)

1

Micrometer calipers

1

   

Optional items

 
   

Flame photometer

1

Osmometer

1

Vortex mixer

1

Constant temperature water-bath

1

Ultrasonic cleaner

1

Refractometer

1

Shaker (wrist-action)

1

Oxygen flask combustion apparatus

1

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